Desflurane-induced Myocardial Protection

December 18, 2013 updated by: Nobuyuki Katori

Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study

This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nobuyuki Katori, M.D.
  • Phone Number: 61608 81-3-3353-1211
  • Email: nbyk@a5.keio.jp

Study Contact Backup

Study Locations

  • Japan
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
        • Contact:
          • Nobuyuki Katori, M.D.
          • Phone Number: 61608 81-3-3353-1211
          • Email: nbyk@a5.keio.jp
        • Contact:
        • Principal Investigator:
          • Hiroshi Morisaki, M.D.
        • Sub-Investigator:
          • Nobuyuki Katori, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.

Exclusion Criteria:

  • Patients younger than 20 years old.
  • Recent myocardial infarction (within 1 year).
  • Renal dysfunction (GFR less than 50ml/min).
  • Known allergy to study drugs including propofol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane
Desflurane inhalation at 1-2 MAC during surgery.
Drug: Desflurane
Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.
Other Names:
  • SUPRANE
Active Comparator: Propofol
5-8 mg/kg/hr infusion during surgery.
Drug: Desflurane
Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.
Other Names:
  • SUPRANE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Troponin I
Time Frame: up to 3 days
up to 3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of ICU stay, Length of hospital stay
Time Frame: up to 2 months after the surgery
up to 2 months after the surgery
Acute myocardial infarction
Time Frame: up to 7 days
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nobuyuki Katori

Collaborators

Baxter Healthcare Corporation

Investigators

  • Study Chair: Makoto Suematsu, M.D., Ph.D, Keio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Desflurane

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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